FDA.reportPublic FDA data

KENTEX

Primary DI
00810003751249
Brand
KENTEX
Company
KENTRON HEALTHCARE, INC.
Model
404085
Catalog number
404085
Device description
VOMIT AND URINE BLUE BAG (EMESIS) WITH RIGID PLASTIC COLLAR AND NOTCHES TO SECURE TWISTED BAG FROM LEAKING.
Published
2018-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FNYBasin, Emesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003751256PackageGS124In Commercial Distribution
00810003751263PackageGS110In Commercial Distribution
00810003751249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003751256008100037512568100037512560810003751256
00810003751263008100037512638100037512630810003751263
00810003751249008100037512498100037512490810003751249

GMDN Terms#

Term, Definition table
TermDefinition
Emesis bagA disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.

Regulatory Flags#

DUNS number
618825723
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750822KENTRON7599252026-06-08
00810003750839KENTRON7599302026-06-08
00810003750846KENTRON7599352026-06-08
00810003750853ENTRON7599402026-06-08
00810003750860KENTRON7599452026-06-08
00810003750877KENTRON7599502026-06-08
00810003750884KENTRON7599552026-06-08
00810003750891KENTRON7599602026-06-08
00810003750907KENTRON7599652026-06-08
00810003750709KENTRON7699502026-06-07
00810003750716KENTRON7699552026-06-07
00810003750723KENTRON7699602026-06-07
00810003750730KENTRON7699652026-06-07
00810003750747KENTRON7699702026-06-07
00810003750754KENTRON7699752026-06-07
00810003750761KENTRON7699802026-06-07
00810003750778KENTRON7699852026-06-07
00810003750785KENTRON7699902026-06-07
00810003750792KENTRON7699952026-06-07
00810003750808KENTRON7691002026-06-07

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00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
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10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
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10840330701386ProCureTwin Med, LLCFNY2024-11-14